Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study

Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection in the real world, observe the adverse drug reactions/ adverse drug events during treatment, and figure out why Tanreqing induced severe allergic reaction happens.

Study Overview

• Status: Completed
• Conditions: Adverse Drug Reaction; Drug Allergy

Detailed Description

As a compound traditional Chinese medicine, Tanreqing Injection was approved by China Food and Drug Administration(CFDA) in 2003, and widely used respiratory disease, such as biofilm related upper respiratory infections, pneumonia and bronchitis. During its 11 years marketing in China, there was hardly any serious adverse drug reactions except for a few cases reported as severe allergic reaction. In this study, clinical pharmacists in selected hospitals will not only record the clinical use and the adverse drug reactions/ adverse drug events of this injection, but also try to figure out why drug-induced severe allergic reaction happens through a nested case-control study. This real world study for Tanreqing Injection with 30400 patients will be conducted from January.2014 to June.2016.

• Study Type: Observational
• Enrollment (Anticipated): 30400

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Anhui
    • Hefei, Anhui, China, 230051
      • Anhui Provincial Children's Hospital
  • Beijing
    • Beijing, Beijing, China, 100072
      • The Fengtai district Hospital of Integrated TCM & WM
    • Beijing, Beijing, China, 100095
      • Beijing Geriatric Hospital
    • Beijing, Beijing, China, 101100
      • The 263rd Hospital of Chinese People's Liberation Army
    • Beijing, Beijing, China, 101149
      • Beijing Luhe Hospital, Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 404000
      • Chongqing Three Gorges Central Hospital
    • Chongqing, Chongqing, China, 400021
      • Chongqing Traditional Chinese Medicine Hospital
    • Chongqing, Chongqing, China, 400014
      • The Third People's Hospital of Chongqing
    • Chongqing, Chongqing, China, 400050
      • Chongqing Jiulongpo First People's Hospital
    • Chongqing, Chongqing, China, 405400
      • Chongqing Kaixian County People's Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Gansu Provincial Hospital of Traditional Chinese Medicine
    • Lanzhou, Gansu, China, 730060
      • Lanzhou Petrochemical General Hospital
  • Guangdong
    • Huizhou, Guangdong, China, 516002
      • The Third People's Hospital of Huizhou
    • Shenzhen, Guangdong, China, 518112
      • The Third People's Hospital of Shenzhen
    • Zhongshan, Guangdong, China, 528403
      • Zhongshan Municipal People's Hospital
  • Guizhou
    • Bijie, Guizhou, China, 551700
      • Bijie First Municipal People's Hospital
    • Guiyang, Guizhou, China, 550003
      • Guiyang Children's Hospital
    • Guiyang, Guizhou, China, 550003
      • Guiyang Pulmonary Hospital
    • Guiyang, Guizhou, China, 550003
      • Guizhou Cancer Hospital
    • Guiyang, Guizhou, China, 550009
      • The 44th Hospital of chinese People's Liberation Army
    • Zunyi, Guizhou, China, 563000
      • Affiliated Hospital of Zunyi Medical College
  • Hainan
    • Haikou, Hainan, China, 570102
      • The Affiliated Hospital of Hainan Medical College
  • Hebei
    • Baoding, Hebei, China, 071700
      • People's Hospital of Rongcheng
    • Cangzhou, Hebei, China, 061000
      • People's hospital of Cangzhou
    • Handan, Hebei, China, 056002
      • First Hospital of Handan City
    • Hejian, Hebei, China, 062450
      • Hejian Municipal People's Hospital
    • Qinhuangdao, Hebei, China, 066000
      • The first hospital of Qinhuangdao
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China, 050082
      • Bethune International Peace Hospital of the Chinese PLA
    • Shijiazhuang, Hebei, China, 051530
      • Hebei Zhaoxian People's Hospital
    • Xinle, Hebei, China, 050700
      • Xinle Municipal Hospital of Hebei
  • Henan
    • Pingdingshan, Henan, China, 467000
      • The 152nd Hospital of chinese People's Liberation Army
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450002
      • Henan Province Hospital of TCM
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430015
      • Hubei Xinhua Hospital
    • Wuhan, Hubei, China, 430033
      • Hubei Zhongshan Hospital Affiliated to Wuhan University
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410006
      • The Fourth Hospital of Changsha
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • The Third Affiliated Hospital of Inner Mongolia Medical College
    • Huhehaote, Inner Mongolia, China, 010030
      • The First Hospital Of Huhhot
    • Huhehaote, Inner Mongolia, China, 010080
      • The fourth Hospital of Inner Mongolia
    • Wulanchabu, Inner Mongolia, China, 012000
      • The Second Hospital of Wulanchabu City
  • Jiangsu
    • Nanjing, Jiangsu, China, 211100
      • Jiangning District Hospital of Traditional Chinese Medicine
    • Yangzhou, Jiangsu, China, 225002
      • The First People's Hospital of Yangzhou City
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
    • Nanchang, Jiangxi, China, 330003
      • The Second Hospital of Nanchang
    • Nanchang, Jiangxi, China, 330006
      • Traditional Chinese Medical Hospital of Jiangxi Province
    • Nanchang, Jiangxi, China, 330008
      • The First Hospital of Nanchang
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130041
      • The Second Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110034
      • Shenyang 242 Hospital
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
    • Yinchuan, Ningxia, China, 750001
      • The First People's Hospital of Yinchuan
    • Yinchuan, Ningxia, China, 750021
      • Chinese Traditional Medicine Hospital of Ningxia Autonomous Region
  • Qinghai
    • Xining, Qinghai, China, 810007
      • Qinghai Women and Childhood Hospital
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
    • Jinan, Shandong, China, 250011
      • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    • Xintai, Shandong, China, 271200
      • Xintai People's Hospital
    • Yantai, Shandong, China, 265200
      • Yantai Municipal Laiyang Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Shanghai Changzheng Hospital
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China, 200081
      • Shanghai First People's Hospital Branch
    • Shanghai, Shanghai, China, 200940
      • Wu Song Central Hospital of Shanghai
    • Shanghai, Shanghai, China, 201199
      • Shanghai Minhang District Central Hospital
  • Shanxi
    • Datong, Shanxi, China, 037006
      • Fifth Hospital of Datong
    • Fenyang, Shanxi, China, 032200
      • Fenyang Hospital of Shanxi Province
    • Jinzhong, Shanxi, China, 030800
      • The Second People's Hospital of Jinzhong
    • Shuozhou, Shanxi, China, 036002
      • The Center Hospital of Shuozhou
    • Taiyuan, Shanxi, China, 030012
      • Maternal and Child Health Care Hospital of Taiyuan
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Maternity and Children Health Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital
    • Chengdu, Sichuan, China, 610031
      • The Third People's Hospital of Chengdu
    • Chengdu, Sichuan, China, 610200
      • ShuangLiu Hospital of Traditional Chinese Medical
    • Dujiangyan, Sichuan, China, 611830
      • DuJiangyan Traditional Chinese Medicine Hospital
    • Nanchong, Sichuan, China, 637300
      • People's Hospital of Nanbu County
  • Tianjin
    • Tianjin, Tianjin, China, 300142
      • The 254th Hospital of chinese People's Liberation Army
    • Tianjin, Tianjin, China, 300381
      • The 464th Hospital of chinese People's Liberation Army
  • Xinjiang
    • Wulumuqi, Xinjiang, China, 830011
      • People's Hospital of Xinjiang Uigur Autonomous Region
  • Yunnan
    • Dali, Yunnan, China, 671099
      • Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali
    • Kunming, Yunnan, China, 650032
      • First Affiliated Hospital of Kunming Medical University
    • Kunming, Yunnan, China, 650101
      • Second Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Zhejiang Provincial Hospital of TCM
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital
    • Wenzhou, Zhejiang, China, 325000
      • Wenzhou Central Hospital
    • Wenzhou, Zhejiang, China, 325027
      • The Second Affiliated Hospital of Wenzhou Medical College
    • Wenzhou, Zhejiang, China, 325699
      • Wenzhou Yueqing People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who use the Tanreqing Injection in selected hospitals in China (including the inpatient and the outpatient(only in some hospitals which can get the information)).

Description

Inclusion Criteria:

• Patients who use the Tanreqing Injection in selected hospitals in China, including inpatient and outpatient.
• Outpatients will be only in some hospitals which can get the patients' complete information.

Exclusion Criteria:

• Patients who are less than 24 months.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Tanreqing; Inpatient using the Tanreqing Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse drug reaction of Tanreqing Injection	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes of the patients who experienced an adverse drug reaction of Tanreqing Injection	Outcomes including cure, improved, null, or death.	30 months
Administration of Tanreqing Injection in real world		30 months
Population characteristics of the adverse drug reaction of Tanreqing Injection		30 months
Off-lable use of Tanreqing Injection		30 months
Drug combination of Tanreqing Injection in real world		30 months

Other Outcome Measures

Outcome Measure	Time Frame
Related Risk Factors in severe allergic reaction of Tanreqing Injection	30 months

Collaborators and Investigators

• Sponsor: Suodi ZHAI
• Collaborators: Peking University; The Second Hospital of Hebei Medical University; West China Hospital; Hubei Cancer Hospital; Shandong Cancer Hospital and Institute; The First Affiliated Hospital of Zhengzhou University; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Gansu Provincial Hospital; The First Hospital of Jilin University; Henan Provincial People's Hospital; People's Hospital of Xinjiang Uygur Autonomous Region; Central South University; The Second Affiliated Hospital of Chongqing Medical University; General Hospital of Ningxia Medical University; Shanghai Changzheng Hospital; Second Affiliated Hospital of Guangzhou Medical University; Wenzhou Central Hospital; Ningbo No. 1 Hospital; Sichuan Provincial People's Hospital; Second Hospital of Jilin University; Yangzhou No.1 People's Hospital; Yunnan Provinical Hospital of Traditional Chinese Medicine; Zhongshan People's Hospital, Guangdong, China; The First Hospital of Qinhuangdao; The 152nd Hospital of chinese People's Liberation Army; People's Hospital of Rongcheng; The Second Affiliated Hospital of Kunming Medical University; Zunyi Medical College; Shanxi Provincial Maternity and Children's Hospital; Jiangxi Provincial People's Hopital; Shenzhen Third People's Hospital; Zhejiang Provincial Hospital of TCM; Cancer Hospital of Guizhou Province; Chongqing Traditional Chinese Medicine Hospital; Shandong University of Traditional Chinese Medicine; Beijing Geriatric Hospital; Hubei Xinhua Hospital; The First Hospital of Nanchang; The Third People's Hospital of Chengdu; Chongqing Three Gorges Central Hospital; Anhui Provincial Children's Hospital; Handan First Hospital; Shanghai Kaibao Pharmaceutical CO.,LTD.; Bethune International Peace Hospital of the Chinese PLA; The 254th Hospital of chinese People's Liberation Army; The 464th Hospital of chinese People's Liberation Army; People's Hospital of Cangzhou; The 44th Hospital of chinese People's Liberation Army; First Affiliated Hospital of Kunming Medical University; ShuangLiu Hospital of Traditional Chinese Medical; People's Hospital of Nanbu County; DuJiangyan Traditional Chinese Medicine Hospital; The Third People's Hospital of Chongqing; The Fourth Hospital of Changsha; Affiliated Yueqing Hospital of Wenzhou Medical University; Shanghai Minhang District Central Hospital; Shanghai First People's Hospital Branch; The Affiliated Hospital of Hainan medical College; Guiyang Children's Hospital; Traditional Chinese Medical Hospital of Jiangxi Province; Jiangning District Hospital of Traditional Chinese Medicine; Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali; Bijie First Municipal People's Hospital; Guiyang Pulmonary Hospital; The 263rd Hospital of Chinese People's Liberation Army; Chongqing Kaixian County People's Hospital; Chongqing Jiulongpo First People's Hospital; Shenyang 242 Hospital; Wu Song Central Hospital of Shanghai; Lanzhou Petrochemical General Hospital; Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region; The First People's Hospital of Yinchuan; Yantai Municipal Laiyang Central Hospital; The Second Hospital of Nanchang; The Second Hospital of Wulanchabu City; Qinghai Women and Childhood Hospital; The Center Hospital of Shuozhou; Hubei Zhongshan Hospital Affiliated to Wuhan University; The Third Affiliated Hospital of Inner Mongolia Medical College; The fourth Hospital of Inner Mongolia; Fenyang Hospital of Shanxi Province; The First Hospital Of Huhhot; Taiyuan Xinghualing Maternity & Child Health Care Center; The Fifth People's Hospital of Datong; The Second People's Hospital of Jinzhong; Hebei Zhaoxian People's Hospital; Hejian Municipal People's Hospital; Xinle Municipal Hospital of Hebei; Beijing Luhe Hospital, Capital Medical University; Fengtai district Hospital of Chinese and Western medicine, Beijing; Xintai People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (ESTIMATE): March 24, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine Injection
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Drug Hypersensitivity
• Other Study ID Numbers: PekingUTH-Pharmacy-003